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Results for “randomized crossover trial”

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PubMed2000

Disposable plastic liners for a colostomy appliance: a controlled trial and follow-up survey of convenience, satisfaction, and costs.

PURPOSE: The effectiveness of a disposable liner designed for a 2-piece colostomy appliance pouch was evaluated. DESIGN: Randomized, crossover trial with follow-up surveys. SETTING AND SUBJECTS: Nineteen participants were recruited from the Mayo Clinic in Scottsdale, Arizona, and the surrounding community. INSTRUMENTS: A Daily Colostomy Care Evaluation Record and tally sheet of times for ostomy care were designed by the authors. METHODS: Participants, acting as their own controls, were randomly assigned to use either an unlined or a lined appliance for 9 days. On day 10, participants switched to the opposite regimen, which was maintained through day 18. They recorded the time required for daily colostomy care and perceptions of the lined and unlined appliances. The volume of ostomy supplies and cost were recorded at baseline, 1, 3, and 5 to 9 months after the initial trial. RESULTS: Odor, bother, perceived severity of leakage, and partner acceptance were better with unlined than lined appliances. Half of the participants were using a liner > or =75% of the time 3 months after the trial. There was no difference in cost when lined versus unlined ostomy systems were compared. Participants who chose to use the liners indicated high satisfaction. Problems noted included an inadequate seal with the liner (58%), inadequate liner size (16%), retention of flatus by the liner (11%), and difficulty removing the full liner (11%). CONCLUSIONS: The study supports recommending liners to patients who have a modest amount of fecal output or flatus. However, patients who are unable to manipulate the seal or have a large output volume are unlikely to find the liners a convenience. Satisfaction with the liners was sufficient to warrant investigation and design of a lined device with an improved design, greater capacity, and tighter seal.

Aged↗

PubMed1984

A comparative trial of ordinary metoprolol tablets and metoprolol sustained-release tablets in hypertensive patients at rest and on exercise.

An open, randomized crossover trial was carried out in 10 patients with hypertension to compare the degree and duration of antihypertensive effect of metoprolol given as 100 mg ordinary tablets twice daily and as single daily doses of a 200 mg sustained-release tablet. Blood pressures and heart rate were measured, at rest and during maximum exercise effort, before treatment, at the second hour after the start of each treatment sequence, and at the end of both 14-day treatment periods: after 12 hours in the case of ordinary metoprolol and after 24 hours with sustained-release metoprolol. The results showed that heart rate was greatly reduced (less than 0.001) both at rest and on exercise at all times studied with both treatments. At rest, blood pressure was significantly reduced except by sustained-release metoprolol at 2 hours. On exercise, blood pressure was also significantly reduced except for the 12-hour value for diastolic pressure with ordinary metoprolol. It is concluded that, for similar reductions in heart rate reflecting satisfactory beta-receptor blockade, the antihypertensive effect of metoprolol given at a dosage of 200 mg per day was more rapid in onset after the ordinary tablet formulation but less marked at 12 hours than at 24 hours after the sustained-release formulation.

Adult↗

PubMed2005

Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives.

Randomized trials have shown that increasing potassium intake lowers blood pressure. However, most previous trials used potassium chloride, whereas potassium in fruits and vegetables is not a chloride salt. It is unclear whether a nonchloride salt of potassium has a greater or lesser effect on blood pressure compared with potassium chloride. We performed a randomized crossover trial comparing potassium chloride with potassium citrate (96 mmol/d, each for 1 week) in 14 hypertensive individuals. At baseline, blood pressure was 151+/-16/93+/-7 mm Hg with a 24-hour urinary potassium of 81+/-24 mmol. During the randomized crossover part of the study, blood pressure was 140+/-12/88+/-7 mm Hg with potassium chloride (24-hour urinary potassium: 164+/-36 mmol) and 138+/-12/88+/-6 mm Hg with potassium citrate (24-hour urinary potassium: 160+/-33 mmol). These blood pressures were significantly lower compared with that at baseline; however, there was no significant difference in blood pressure between potassium chloride and potassium citrate, mean difference (95% confidence interval): 1.6 (-2.3 to 5.6) mm Hg for systolic and 0.6 (-2.4 to 3.7) mm Hg for diastolic. Our results, in conjunction with the evidence from many previous trials that potassium chloride has a significant blood pressure-lowering effect, suggest that potassium citrate has a similar effect on blood pressure as potassium chloride. These results support other evidence for an increase in potassium intake and indicate that potassium does not need to be given in the form of chloride to lower blood pressure. Increasing the consumption of foods high in potassium is likely to have the same effect on blood pressure as potassium chloride.

Adult↗

PubMed1995

The insulin-like growth factor axis and collagen turnover in asthmatic children treated with inhaled budesonide.

Serum concentrations of growth hormone-dependent insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3), the carboxy terminal propeptide of type I procollagen (PICP), the carboxy terminal pyridinoline cross-linked telopeptide of type I collagen (ICTP) and the amino terminal propeptide of type III procollagen (PIIINP) were studied in 14 prepubertal children with asthma (mean age 9.7 years) during treatment with inhaled budesonide. The study design was a randomized, crossover trial with two double-blind treatment periods (200 and 800 micrograms) and one open, non-randomized treatment period (400 micrograms). All periods were 18 days' duration. Budesonide treatment was associated with a dose-related suppressive trend in serum concentrations of PIIINP when the 400 micrograms period was included (p < 0.01; z = -2.7) and when it was excluded from the calculations (p < 0.01; z = -2.6), indicating reduced synthesis of type III collagen. A similar trend was observed in ICTP levels when the 400 micrograms period was excluded from the calculations (p = 0.05; z = -1.9). No other statistically significant variations were seen.

Administration, Inhalation↗

PubMed2001

Impact of inspired gas mixtures on preoperative infants with hypoplastic left heart syndrome during controlled ventilation.

BACKGROUND: Management strategies for preoperative infants with hypoplastic left heart syndrome (HLHS) include increased inspired nitrogen (hypoxia) and increased inspired carbon dioxide (hypercarbia). There are no studies directly comparing these 2 therapies in humans. This study compares the impact of hypoxia versus hypercarbia on oxygen delivery, under conditions of fixed minute ventilation. METHODS AND RESULTS: Ten anesthetized and paralyzed preoperative infants with HLHS were evaluated in a prospective, randomized, crossover trial comparing hypoxia (17% FIO(2)) with hypercarbia (2.7% FICO(2)). Each patient was treated in a random order (10 minutes per condition) with a recovery period (15 to 20 minutes) in room air. Arterial (SaO(2)) and superior vena caval (SvO(2)) co-oximetry and cerebral oxygen saturation (ScO(2)) measurements were made at the end of each condition and recovery period. ScO(2) was measured by near infrared spectroscopy. Hypoxia significantly decreased both SaO(2) (-5.2+/-1.1%, P=0.0014) and SvO(2) (-5.6+/-1.7%, P=0.009) compared with baseline, but arteriovenous oxygen saturation (AVO(2)) difference (SaO(2)-SvO(2)) and ScO(2) remained unchanged. Hypercarbia decreased SaO(2) (-2.6+/-0.6%, P=0.002) compared with baseline but increased both ScO(2) (9.6+/-1.8%, P=0.0001) and SvO(2) (6+/-2.2%, P=0.022) and narrowed the AVO(2) difference (-8.5+/-2.3%, P=0.005). Both hypoxia and hypercarbia decreased the balance between pulmonary and systemic blood flow (Qp:Qs) compared with baseline. CONCLUSIONS: In preoperative infants with HLHS, under conditions of anesthesia and paralysis, although Qp:Qs falls in both conditions, oxygen delivery is unchanged during hypoxia and increased during hypercarbia. These data cannot differentiate cerebral from systemic oxygen delivery.

Administration, Inhalation↗

PubMed1987

Nicardipine in the treatment of Raynaud's phenomenon: a randomized double-blind trial.

The efficacy of the calcium-channel blocker nicardipine in the treatment of Raynaud's phenomenon was assessed in a prospective, double-blind, randomized, crossover trial in 20 patients. Each patient received nicardipine 20 mg or placebo three times a day for two weeks and then was crossed over for two weeks. Nicardipine significantly decreased the frequency and severity of Raynaud's phenomenon as compared with placebo. The authors conclude that nicardipine is effective in the treatment of Raynaud's phenomenon.

Adolescent↗

PubMed1999

Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. German Humalog-CSII Study Group.

OBJECTIVE: Insulin lispro is an analog of human insulin with a faster onset and a shorter duration of action than regular human insulin. Efficacy and tolerability of insulin lispro in continuous subcutaneous insulin infusion (CSII) treatment were assessed in an open randomized crossover trial comparing insulin lispro and regular human insulin, both applied with insulin pumps. RESEARCH DESIGN AND METHODS: A total of 113 type 1 patients (60 male, 53 female, age [mean +/- SD] 37 +/- 12 years, duration of diabetes 19 +/- 9 years) participated in this open, randomized crossover study. Both insulins were applied for 4 months each with the appropriate intervals between the prandial insulin bolus and the meal (human insulin: 30 min; lispro: 0 min). Observation parameters were HbA1c, daily and postprandial blood glucose profiles, adverse events, rate of hypoglycemic and hyperglycemic events, number of catheter obstructions, and treatment satisfaction as assessed with an international validated questionnaire. RESULTS: The patients were well controlled with a mean HBA1c of 7.24 +/- 1.0% at baseline. HbA1c decreased in both treatment periods, but it was better during insulin lispro treatment (insulin lispro: 6.8 +/- 0.9%, regular human insulin: 6.9 +/- 1.0%, Friedman's rank-sum test: P < 0.02). In addition, the 1-h and 2-h postprandial rises in blood glucose were significantly lower (P < 0.001 for each meal) with insulin lispro, resulting in smoother daily glucose profiles as compared with regular human insulin. No significant differences were reported for the rate of hypoglycemia (mean +/- SD [median]: insulin lispro 12.4 +/- 13.9 [8], regular human insulin 11.0 +/- 11.2 [8]), for the rate of catheter obstructions (42 events in each treatment arm), and for the number and type of adverse events. No severe case of ketoacidosis was seen during insulin lispro treatment, whereas one case was reported during therapy with regular human insulin. Treatment satisfaction was better when patients were treated with insulin lispro. CONCLUSIONS: Insulin lispro is a suitable and very convenient pump insulin that may result in an improvement of long-term glucose control during CSII treatment. Its safety profile does not differ from that of regular human insulin.

Adult↗

PubMed2002

Online hemodiafiltration versus acetate-free biofiltration: a prospective crossover study.

Online hemodiafiltration (online HDF) and acetate-free biofiltration (AFB) are 2 innovative renal replacement therapies. Convincing evidence has shown that both techniques are superior to conventional hemodialysis in many aspects. The aim of the present investigation was to compare online HDF and AFB in 12 stable maintenance hemodialysis patients in a prospective, randomized crossover trial. Twelve stable dialysis patients, age 49.7 +/- 11.3 years and on dialysis for 83.5 +/- 76.7 months, were treated prospectively and randomly by either AFB, predilution HDF (pre-HDF), or postdilution HDF (post-HDF) for a total of 36 weeks using exclusively F60S high-flux dialyzers. Routine blood biochemical tests, bone metabolism parameters, and clearance for both small and larger molecular weight substances were measured at defined intervals. During the trial period inter- and intradialysis symptoms, e.g., hypotensive episodes and intradialysis arterial blood gas analyses, were recorded. Both online HDF and AFB were well accepted by the overwhelming majority of patients and also by the dialysis staff. Pretreatment sodium, total and ionized calcium, chloride, bicarbonate, and urea did not differ within or between the 3 treatment groups. Potassium increased slightly in HDF patients while phosphate and beta2-microglobulin (beta2-M) decreased in all groups. After dialysis, AFB patients exhibited a significantly higher bicarbonate concentration and lower potassium level when identical potassium concentrations in dialysate were used. Patients receiving AFB manifested less intradialysis partial pressure of oxygen drop and partial pressure of carbon dioxide rise than those on HDF treatments. HDF treatments could afford higher single-pool and double-pool Kt/V, higher effective urea and beta2M clearance, and lower total interdialysis symptom scores than the AFB treatment method. While bone metabolism parameters did not differ between the 3 dialysis modalities, some parameters such as deoxypyridinoline in HDF and osteocalcin, pyridinoline, and deoxypyridinoline in AFB deteriorated at the end of the crossover study. Aluminum concentration decreased progressively to about one-third of prestudy values at the end of the study with all 3 treatments. AFB was associated with a lower predialysis mean arterial pressure (MAP), a smaller drop in MAP during treatment, and similar hypotension episodes compared with the 2 HDF treatments. Albumin concentration showed a trend to decrease during the first 2 months of the trial period followed by a slight increase thereafter but still significantly lower than initial value at the end of crossover. Both online HDF and AFB share most of the features of optimal renal replacement therapy. Online HDF is superior to AFB in such aspects as increased delivered dialysis dose both for small and larger molecular weight toxins and less interdialysis symptoms. On the other hand, AFB is associated with a smaller effect on arterial blood gas values and improved intradialysis hemodynamic tolerance. Some dialysis-related symptoms and complications in the case of our AFB practice could be attributable, at least in part, to low dialysate calcium level.

Adult↗

PubMed1989

Oxybutinin versus propantheline in the management of detrusor instability. A patient-regulated variable dose trial.

Two of the principal drugs used to treat detrusor instability, oxybutinin hydrochloride and propantheline bromide, were compared using clinical and urodynamic outcome measures in a randomized crossover trial with a patient-regulated variable dose regimen. Of the 23 women in the trial, 14 reported subjective improvement during treatment with oxybutinin hydrochloride compared with 11 during treatment with propantheline bromide. Apart from a greater increase in the maximum cystometric capacity with oxybutinin, there were no other objective differences between the two drugs. Oxybutinin significantly delayed the first desire to void, increased the maximum cystometric capacity and reduced the maximum detrusor pressure rise on filling. Propantheline significantly increased the maximum cystometric capacity and reduced the maximum detrusor pressure rise on filling. Three patients stopped treatment due to side-effects.

Adult↗

PubMed1997

In vivo diaphragm metabolism: comparison of paced and inspiratory resistive loaded breathing in piglets.

OBJECTIVE: We hypothesized that spontaneous, loaded diaphragm contractions would lead to diaphragm fatigue, which would correlate with inadequate oxidative metabolism as measured by phosphorus-31 nuclear magnetic resonance spectroscopy. DESIGN: Prospective, randomized, crossover trial. SETTING: University hospital research laboratory. SUBJECTS: Eight piglets, 4 to 6 wks of age. INTERVENTIONS: Each animal underwent, in random order, a 20-min period of diaphragm pacing and a 45-min period of loaded spontaneous breathing, separated by a 20-min recovery period. Mechanical ventilation was used during diaphragm pacing to maintain a PaCO2 of 35 to 45 torr (4.7 to 6.0 kPa) and a PaO2 of > 100 torr (> 13.3 kPa). During spontaneous breathing, inspiratory loading was achieved with a 2.0-mm inner diameter endotracheal tube in the breathing circuit. MEASUREMENTS AND MAIN RESULTS: During pacing, mean transdiaphragmatic pressure decreased by 35%, from 23 +/- 5 (SD) to 15 +/- 3 mm Hg (p < .05), and this decrease correlated with a 335% increase in the ratio of inorganic phosphate to phosphocreatine, from 0.23 +/- 0.1 to 1.0 +/- 0.7 (p < .05). During loaded spontaneous breathing, arterial pH decreased from 7.42 +/- 0.06 to 7.25 +/- 0.05 (p < .05), secondary to an increase in PaCO2 from 41 +/- 4 to 65 +/- 11 torr (5.3 +/- 0.5 to 8.7 +/- 1.5 kPa) (p < .05). Despite respiratory acidosis, there was no decrease in trandiaphragmatic pressure during the period of loaded breathing, nor was any change in the ratio of inorganic phosphate to phosphocreatine seen. CONCLUSIONS: Diaphragm fatigue in a pacing model correlates with inadequate oxidative metabolism. In contrast, severe inspiratory resistive loaded breathing did not result in changes in oxidative metabolism or decreased diaphragm force output, despite hypercapnia and respiratory acidosis.

Adenosine Triphosphate↗

PubMed2001

A placebo-controlled, crossover trial of granisetron in SRI-induced sexual dysfunction.

BACKGROUND: Sexual side effects are commonly associated with serotonin reuptake inhibitor (SRI) therapy. The mechanism underlying SRI-induced sexual dysfunction has been hypothesized to be mediated by direct serotonergic effects. Evidence from open-label reports suggests that cyproheptadine, nefazodone, mirtazapine, and mianserin, which block one or more serotonin receptors, may reverse sexual side effects. The current study was a prospective, randomized, crossover trial comparing granisetron, a serotonin-3 antagonist, with placebo in outpatients who developed sexual dysfunction during SRI treatment. METHOD: Thirty-one outpatients who were currently experiencing sexual dysfunction associated with SRIs were randomly assigned to double-blind treatment with granisetron (1-1.5 mg) or placebo for use 1 to 2 hours prior to sexual activity. Patients rated sexual symptoms after each trial using the Sexual Side Effect Scale (SSES). After 4 trials of the medication, patients crossed over to the other treatment for 4 more trials. RESULTS: Twenty patients received at least 1 dose of placebo and granisetron. Analysis by repeated-measures analysis of variance showed no significant effects of granisetron relative to placebo. Significant improvement between baseline and treatment-phase SSES scores was observed for both granisetron (p = .0004) and placebo (p = .0081). The study medication was generally well tolerated. CONCLUSION: The results of this study do not support the efficacy of granisetron (1-2 mg) in the treatment of SRI-associated sexual side effects. A significant placebo response may be associated with the treatment of SRI-induced sexual dysfunction.

Ambulatory Care↗

PubMed1988

Comparison of gemfibrozil and clofibrate on serum lipids in familial combined hyperlipidemia. A randomized placebo-controlled, double-blind, crossover clinical trial.

A randomized double blind, placebo-controlled crossover design was used to determine the efficacy of gemfibrozil and clofibrate in the treatment of familial combined hyperlipidemia and to determine which one of these agents would be more effective. Sixteen patients, 12 men and 4 women, mean age 49.5 years (40-68 yrs), had the entry criteria of increased cholesterol and/or triglyceride with an increase in triglyceride and/or cholesterol in one or more first degree relatives and/or family history of premature cardiovascular disease. Patients received 6 weeks of placebo followed by clofibrate 1000 mg bid or gemfibrozil 600 mg bid for 12 weeks, placebo for 6 weeks and the other drug for 12 weeks. Plasma total cholesterol, triglycerides, HDL-C, LDL-C, apo B and apo A-I were measured every 6 weeks during the study. Gemfibrozil was associated with a significant (P less than 0.05) decrease in plasma triglyceride concentration compared to placebo but it was not significantly different compared to clofibrate. For ease of comparison, the mean value for serum triglycerides during gemfibrozil treatment (average of the 6 and 12 week measurements) was calculated and was 232 +/- 198 mg/dl (mean +/- 1 SD) compared to the average of the placebo treatment values of 381 +/- 410 mg/dl and the average value during the clofibrate treatment period of 217 +/- 178 mg/dl. HDL-C was significantly (P less than 0.05) increased with both drugs and to the same extent.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1993

Interferon-alpha in mixed cryoglobulinemia patients: a randomized, crossover-controlled trial.

The effects of interferon-alpha (IFN-alpha) on clinical and serologic manifestations of mixed cryoglobulinemia (MC) were investigated by randomized, crossover-controlled trial in 26 patients. The trial alternated 6 months with and 6 months without IFN-alpha therapy (2 x 10(6) IU daily for a month, then every other day for 5 months). In 22 patients, pretreatment steroid dosage remained unchanged during the study. Six patients dropped out (three because of side effects), whereas another 20 patients experienced a significant improvement of purpura (P < .02) and serum transaminases (P < .005) during IFN-alpha treatment. The presence of clinical improvement was supported by the outcome measurements of several immunologic parameters. In particular, serum cryoglobulins were significantly reduced (P < .04) during IFN-alpha therapy. A rebound phenomenon of clinical and serologic parameters was observed after IFN-alpha discontinuation. In addition, no variations were recorded during 6 months without therapy. Hepatitis C virus (HCV) RNA was detected in 91% (20/22) of our MC patients; in 2/13 cases HCV RNA was no longer detectable in serum samples after IFN-alpha therapy. Thus, IFN-alpha could be considered as treatment for MC in patients with HCV seropositivity.

Alanine Transaminase↗

PubMed1999

Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects.

OBJECTIVE: To study the pharmacokinetic and pharmacodynamic profile of insulin aspart (a new fast-acting human insulin analog) after subcutaneous administration in the deltoid, abdominal, and thigh sites and to compare this profile with regular human insulin (Novolin; Novo Nordisk A/S, Copenhagen). RESEARCH DESIGN AND METHODS: A total of 20 healthy subjects were studied in a single-center six-period double-blind randomized crossover trial with 6 study days and a washout period of 1 week between each single daily dose of the trial drug. Subjects were randomized to receive a single dose of 0.2 U/kg of insulin aspart or regular insulin on each of the 6 study days in three different sites (the deltoid, the abdomen, and the thigh) during a 10-h euglycemic clamp (two drugs and three injection sites). Pharmacokinetic and pharmacodynamic measurements were derived from blood sample measurements of glucose, insulin, and C-peptide during these clamps. RESULTS: The pharmacodynamic data from the euglycemic clamp study showed that, regardless of injection site, the maximal glucose infusion rate (GIR Cmax) was greater and occurred at an earlier time (GIR Tmax) after administration of insulin aspart than regular insulin (GIR Cmax: abdomen 813 vs. 708, deltoid 861 vs. 736, and thigh 857 vs. 720 g/min, P < 0.05 for all; GIR Tmax: abdomen 94 vs. 173, deltoid 111 vs. 192, and thigh 145 vs. 193 g/min, P < 0.05 for all). Pharmacokinetic parameters were also consistent with faster absorption and higher peak insulin concentrations after insulin aspart administration. From all sites, the peak insulin concentration (Cmax) was higher and occurred earlier (Tmax) after administration of insulin aspart than of regular insulin (Cmax: abdomen 501 vs. 260, deltoid 506 vs. 252, thigh 422 vs. 220 pmol/l, P < 0.001 for all sites; Tmax: abdomen 52 vs. 109, deltoid 54 vs. 98, and thigh 60 vs. 107 min, P < 0.01 for all sites). The absorption and glucose-lowering action of insulin aspart did not differ between sites (similar GIR Cmax, Tmax, and area under the curve parameters). However, the duration of the glucose-lowering effect was up to 34 min shorter (P < 0.01) for the abdomen injections than for the deltoid or thigh injections (lower time of 50% glucose disposal). In addition, the amount of glucose infused was significantly lower by 10-14% in the abdomen than in other sites. CONCLUSIONS: Subcutaneous administration of insulin aspart causes a more rapid and intense maximal effect compared with regular insulin during euglycemic clamp studies in nondiabetic subjects. Abdominal administration of insulin aspart has a shorter duration of glucose-lowering effect compared with administration in the deltoid or thigh.

Absorption↗

PubMed2001

Randomized comparison of a dry powder inhaler and metered dose inhaler with spacer in management of children with asthma.

OBJECTIVE: Comparison of the clinical efficacy of a transparent, DPI (transparent Rotahaler) with MDI and spacers in childhood asthma. DESIGN: Open, randomized, crossover trial. SETTINGS: Out patient clinic of a referral pediatric center. METHODS: Thirty (mean 6.1 +/-2.7 years) children with moderate persistent asthma were randomized to receive long-term medications by a DPI or a metered dose inhaler with spacer for six weeks and then crossed over to receive the same drugs for another period of six weeks after an initial run in period of one week for training in inhalation techniques. The preventative therapy consisted of inhaled Beclomethasone dipropionate (600 mcg/day) and Salbutamol as per requirement. The patients were monitored by a symptom diary, weekly PEFR, and PEFR variability by the parental record of PEFR measurements at home with Mini Wright s Peakflow meter in accordance with the Consensus guidelines. RESULTS: Comparisons made on weekly symptom scores, PEFR at interval visits, PEFR variability, additional beta sympathomimetic use and acute exacerbations of asthma did not reveal any statistically significant differences during the two treatment periods (>0.05). CONCLUSION: Metered dose inhaler and dry powder inhaler have equal efficacy in anti-inflammatory therapy of bronchial asthma in children.

Anti-Asthmatic Agents↗

PubMedDate not supplied

Closed suctioning of intubated neonates maintains better physiologic stability: a randomized trial.

OBJECTIVE: To evaluate the physiological variance in a closed (CS) vs an open suction (OS) protocol in intubated infants. STUDY DESIGN: Infants were stratified into three weight groups in a randomized crossover trial. Heart rate, respiratory rate, blood pressure, oxygen saturation, transcutaneous oxygen and carbon dioxide, and end-tidal carbon dioxide were recorded prior to suctioning, during suctioning, and recovery to baseline. Following the procedures, recovery time to baseline parameters was measured. Data were analyzed using repeated measures ANOVA. RESULTS: Overall, there was significantly less deviation from baseline physiological parameters with CS. Infants <1000 g had clinically significant decreases in heart rate with the OS method (-18% OS vs -6% CS; p=0.016). Recovery time in the OS group was twice that of the CS cohort (4 vs 2 minutes; p<0.001). CONCLUSION: CS maintains better physiologic stability in intubated infants.

Cross-Over Studies↗

PubMed1984

Lorcainide. A comparative trial with quinidine gluconate in patients with previously untreated ventricular arrhythmias.

The efficacy of a new antiarrhythmic agent, lorcainide, was compared with that of quinidine gluconate in a fixed-dose, randomized, crossover trial. Of 26 previously untreated patients with frequent ventricular ectopic beats documented by 24-hour ambulatory monitoring, 17 completed four weeks of therapy with quinidine and 12 with lorcainide. Of 22 patients receiving both drugs, early termination of therapy due to side effects occurred in ten (45 percent) patients receiving lorcainide and five (23 percent) receiving quinidine. Lorcainide (100 mg twice daily or three times daily, dependent on body weight) effectively suppressed ventricular arrhythmias in seven of 12 (58 percent) patients completing four weeks of therapy, and suppression by quinidine gluconate (324 mg three times daily) occurred in five of 12 (59 percent) patients. We conclude that in a dose of 100 mg twice or three times daily, lorcainide is as effective as quinidine gluconate, 324 mg three times daily, for the suppression of chronic ventricular arrhythmias. However, the high incidence of adverse reactions experienced with lorcainide make it an unacceptable agent for first-line antiarrhythmic therapy.

Adult↗

PubMed2003

Influence of triacylglycerol structure on the postprandial response of factor VII to stearic acid-rich fats.

BACKGROUND: The consumption of a synthetic, randomized, stearic acid-rich triacylglycerol results in decreased postprandial lipemia and activated factor VII (FVII:a) compared with cocoa butter (a nonrandomized, symmetrical, stearic acid-rich triacylglycerol). It was hypothesized that this difference is a consequence of the differences in structure between the 2 triacylglycerols. OBJECTIVE: The objective was to test whether the consumption of randomized cocoa butter decreases postprandial lipemia and FVII:a. DESIGN: A randomized crossover trial with 17 male subjects compared the effects of meals containing 50 g fat provided as a symmetrical (cocoa butter) or an asymmetrical (randomized cocoa butter) triacylglycerol on postprandial changes in lipids, chylomicron composition, and FVII:a. RESULTS: After randomization, the postprandial area under the curve for plasma triacylglycerol decreased by 41% (P < 0.01). At 3 h the plasma concentrations of triacylglycerol, palmitic acid, stearic acid, and oleic acid were 26%, 18%, 34%, and 19% lower, respectively. The proportion of oleic acid in the sn-2 position of the chylomicron triacylglycerol was reduced from 67.4 mol% to 35.9 mol% and resulted in an increase in the proportion of stearic acid in the sn-2 position from 9.2 mol% to 25.4 mol%. FVII:a did not increase 6 h after consumption of the randomized cocoa butter (: 1.2; 95% CI: -2.7, 4.6 U/L) but increased significantly (: 7.7; 95% CI: 2.5,12.9 U/L) 6 h after consumption of the unrandomized cocoa butter. CONCLUSIONS: Symmetrical stearic acid-rich triacylglycerol with oleic acid in the sn-2 position appears to be absorbed more rapidly than is asymmetrical triacylglycerols with long-chain saturated fatty acids in the sn-2 position, which leads to activation of FVII.

Adult↗